NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins (NATURE32)

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Hemodialysis

Treatments: Dietary Supplement: Placebo; Device: DVB cartridge; Dietary Supplement: Symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03946176

XUANRO4-NATURE 3.2

Details and patient eligibility

About

The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD).

The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins).

The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure.

This combined approach will be aimed at achieving two main objectives:

1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
2. reduction of inflammation markers and oxidative stress and reduction of intestinal permeability

Enrollment: 16 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CKD patients on bicarbonate hemodialysis
• Aged between 30 to 65
• BMI between 18.5 and 29.9
• Omnivore diet
• Informed consent signed

Exclusion criteria

• Use of antibiotics or probiotics up to 30 days prior to recruitment
• Chronic gastrointestinal disorders
• Systemic inflammatory diseases
• Suspicion or clinical diagnosis of malignancy
• Chronic liver disease
• Treatment with corticosteroids or immunosuppressive drugs
• Psychiatric conditions reducing the compliance to treatment protocols

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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16 participants in 2 patient groups, including a placebo group

Symbiotic

Experimental group

Description:

HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge

Treatment:

Device: DVB cartridge

Dietary Supplement: Symbiotic

Placebo

Placebo Comparator group

Description:

HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge

Treatment:

Device: DVB cartridge

Dietary Supplement: Placebo